Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies.

Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncologie Pierre Fabre Dermatologie Eau Thermale Avène Klorane Ducray René Furterer A-Derma Naturactive Pierre Fabre Oral Care.

Established in the Occitanie region since its creation and manufacturing over 95% of its products in France the Group employs some 10000 people worldwide. Its products are distributed in about 130 countries.86% of the Pierre Fabre Group is held by the Pierre Fabre Foundation a government-recognized public-interest foundation while a smaller share is owned by its employees via an employee stock ownership plan.

In 2019 Ecocert Environment assessed the Groups corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard and awarded it the Excellence level.

Pierre Fabre is recognized as one of the Worlds Best Employers 2021 by Forbes. Our group is ranked in the Top 3 in the cosmetics industry and in the Top 10 in the pharmaceutical industry worldwide.

Your mission

The Biometry Department at Pierre Fabre supports all drugs being developed by the company. The department encompasses Data Management Programming and Statistics working cohesively to ensure the successful completion of both Randomized Controlled trials and Real-World evidence studies.

We are seeking a highly skilled and proactive Clinical Development Safety Statistics Expert to join our Biometry Department and the Biometry Leadership Team based in Toulouse (31 Oncopole) or Boulogne (92). This senior role is central to the safety oversight of clinical development programmes with a particular emphasis on safety signal detection benefitrisk evaluation and regulatory compliance. The successful candidate will serve as the internal representative and process owner for clinical development safety leading the harmonization and implementation of a company-wide safety signal detection framework and working closely with the Head of Clinical Safety Head of Clinical Development Medical Directors Data Managers Statistical Programmers and Statisticians.

Your role within a pioneering company in full expansion:

Key Responsibilities:

• Lead the design and implementation of safety signal detection processes for clinical development programmes by providing expert statistical support ensuring early identification and evaluation of emerging safety risks.
• Provide statistical leadership specific to safety on the entire Pierre Fabre R&D portfolio contributing to the conception of Controlled Trials and safety analysis plan.
• Coordinate periodic safety reviews at the programme level synthesising data from AEs SAEs and other relevant sources and supporting relevant R&D stakeholders in benefitrisk assessments.
• Lead the development and maintenance of safety analytics reporting tools in partnership with relevant R&D stakeholders.
• Serve as the primary point of contact in the Biometry Department for safety-related matters on the entire Pierre Fabre R&D portfolio providing expert guidance to internal and external stakeholders.
• Collaborate with clinicians medical writers and regulatory partners to interpret safety data and communicate findings effectively.
• Oversee the selection and management of CROs and external vendors for safety analytics and signal detection activities.
• Program and/or validate statistical analyses using SAS or R software
• Ensure compliance with international regulatory guidelines (ICH EMA FDA) and internal procedures.
• Support the harmonization of safety processes across all clinical development programmes including the deployment of pilot projects and the scaling of best practices.
• Represent Pierre Fabre in external clinical safety networks working groups and industry conferences to enhance the departments visibility and reputation.

This position is compatible with teleworking up to 2 days a week according to company rules.

We offer an attractive remuneration/benefits package: Incentives profit-sharing Pierre Fabre shareholding with matching contribution health and provident insurance 16 days of holidays (RTT) in addition to 25 days of personal holidays public transport participation very attractive CE...

Your skills at the service of innovative projects:

• Advanced degree in Statistics (Masters Degree or PhD) or a related field.
• A minimum of 10 years of experience in the pharmaceutical industry and/or within laboratories (Sponsors) and Contract Research Organizations (CROs).
• Strong experience in oncology clinical trials.

Mandatory Skills:

• Advanced expertise in safety signal detection benefitrisk evaluation and clinical trial methodology.
• Excellent knowledge of clinical safety processes and tools including safety analytics and signal detection.
• Excellent knowledge of international scientific and regulatory guidelines (ICH EMA FDA etc.).
• Excellent written and verbal communication skills in English
• Excellent communication and cooperation skills with a rigorous and pragmatic approach.
• Creativity proactivity rigor autonomy and collaborative spirit.
• Strong ability to manage multiple projects simultaneously and maintain organization.
• Strong analytical skills with the ability to provide recommendations and propose/implement effective solutions.
• Proficiency in at least one of the following two statistical software: SAS or R

Optional Skills

• Knowledge of machine learning and AI techniques applied to safety analytics
• Familiarity with biomarker data and its applications in randomized controlled trials designs

We are convinced that diversity is a source of fulfillment social balance and complementarity for our employees which is why our offers are open to all without restriction.